Vadim Tsvetnitsky, Associate

Dr. Tsvetnitsky is an Associate in Alba Biologics Group. Vadim is a results-oriented business-savvy consultant with over 15 years of experience in the biotechnology field developed under a diverse set of influences. His commitment to the clients is to provide excellence and integrity with advice, complemented by absolute confidentiality, dependable project management, timely delivery and responsive customer service. Vadim's scientific expertise in biotech R&D, developing protein and mAb-based therapeutics, is enhanced by practical familiarity with industry regulatory requirements, GLP, GMP and ICH guidelines, and all stages of drug development. He is dedicated to providing practical and implementable recommendations to meet CMC needs of his clients in:

1. Evaluating current methods of production, purification, formulation and characterization for their suitability for scale-up and technical transfer
2. Resolution of technical difficulties in the current methods
3. Manufacturing process development
4. Formulation development
5. Analytical and assay development
6. Technology transfer and scale-up

Vadim has a particular expertise on development of PEGylated proteins and on outsourcing options for contract manufacturing for recombinant proteins and monoclonal antibodies, pre-clinical safety, PK/PD and toxicology studies.

Dr. Tsvetnitsky graduated with a Ph.D from the School of Pharmacy, University of London, United Kingdom and with a M.Sc at Moscow Institute of Fine Chemical Technology, Russia. In addition Dr. Tsvetnitsky gained postdoctoral experience at the London Regional Cancer Centre, Canada; Odense University in Denmark, and at the Institute of Biochemistry and Physiology of Microorganisma in Russia.